baclofen

Generic: baclofen

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 15 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1868
Product ID 70771-1868_2c2eb58e-8920-43f4-aaa9-6f5add3b35ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211659
Listing Expiration 2026-12-31
Marketing Start 2024-06-20

Pharmacologic Class

Established (EPC)
gamma-aminobutyric acid-ergic agonist [epc]
Mechanism of Action
gaba a agonists [moa] gaba b agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711868
Hyphenated Format 70771-1868

Supplemental Identifiers

RxCUI
197391 197392 430902 2679605
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name baclofen (source: ndc)
Generic Name baclofen (source: ndc)
Application Number ANDA211659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70771-1868-1)
source: ndc

Packages (1)

70771-1868-1 100 TABLET in 1 BOTTLE (70771-1868-1)

Ingredients (1)

baclofen (15 mg/1)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c2eb58e-8920-43f4-aaa9-6f5add3b35ae", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902", "2679605"], "spl_set_id": ["bb5c6faa-2933-44d1-8706-8302150be734"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1868-1)", "package_ndc": "70771-1868-1", "marketing_start_date": "20240620"}], "brand_name": "Baclofen", "product_id": "70771-1868_2c2eb58e-8920-43f4-aaa9-6f5add3b35ae", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "70771-1868", "generic_name": "Baclofen", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "15 mg/1"}], "application_number": "ANDA211659", "marketing_category": "ANDA", "marketing_start_date": "20240620", "listing_expiration_date": "20261231"}